DeviceClearance

Product code CHH— Clinical Chemistry

CHOLESTEROL REAGENT

Classification name
Enzymatic Esterase--Oxidase, Cholesterol
Device class
Class 1
Regulation
21 CFR 862.1175
Advisory panel
Clinical Chemistry
Total cleared
230
First cleared
Most recent

Market context for product code CHH

FDA has cleared 230 devices under product code CHH between 1976 and 2025, filed by 129 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

last 15 years

Top applicants under product code CHH

Recent clearances under product code CHH

1–100 of 230

Data sourced from openFDA. This site is unofficial and independent of the FDA.